ERVEBO
STN: 125690
Proper Name: Ebola Zaire Vaccine, Live
Tradename: ERVEBO
Manufacturer: Merck Sharp & Dohme LLC
Indication:
- ERVEBO is a vaccine indicated for For the prevention of disease caused by Zaire ebolavirus in individuals 12 months of age and older.
Product Information
- Package Insert - ERVEBO
- Patient Information - ERVEBO
- Demographic Subgroup Information – ERVEBO (Ebola Zaire Vaccine, Live)
Refer to Section 1.1 of the Clinical Review Memo for information about participation in the clinical trials and any analysis of demographic subgroup outcomes that is notable.
Supporting Documents
- July 27, 2023 Approval Letter - ERVEBO
- July 27, 2023 Clinical Review Memo - ERVEBO
- Statistical Review and Evaluation - ERVEBO
- September 16, 2022 Approval Letter - ERVEBO
- December 19, 2019 Approval Letter - ERVEBO
- December 19, 2019 Summary Basis for Regulatory Action - ERVEBO
- Statistical Review - ERVEBO
- Approval History, Letters, Reviews, and Related Documents - ERVEBO